NCT00031746

Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels

Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen (PSA) levels. PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels.

Detailed description

OBJECTIVES: * Compare the reduction in the rate of prostatic cellular proliferation in patients with an elevated PSA (5 to 10 ng/mL) and a negative biopsy for prostate cancer when treated with daily soy protein supplements vs placebo. * Compare the effect of these regimens on additional biomarkers of prostate cancer (PSA, high-grade prostate intraepithelial neoplasia, induction of apoptosis, sex steroid receptor expression, and loss of glutathione S-transferase-pi) in these patients. * Compare the effect of these regimens on quality of life, including urinary and sexual function, in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to race (Caucasian vs African American). After 2 weeks of daily oral placebo, patients are randomized to 1 of 2 arms. * Arm I: Patients receive oral soy protein supplement daily for 12 months. * Arm II: Patients receive oral placebo daily for 12 months. Quality of life is assessed at baseline and at 6 and 12 months. PROJECTED ACCRUAL: A total of 160 patients (80 per arm) will be accrued for this study within 12 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	soy protein isolate	25 mg daily
DIETARY_SUPPLEMENT	casein proteins	25 mg daily

Timeline

• Start date: 2000-02-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2003-01-27
• Last updated: 2016-07-19

Locations

5 sites across 1 country: United States